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This blue-chip guide adds quality to the pharmaceutical clinical development process by detailing the need for, and stressing the importance of, an independent audit of clinical data to protect participants and validate study results. Examines the use of personal computers, the Internet, and third-party organizations to assist in data validation! Positioning the audit as the only reliable tool to verify that a drug has been shown to be safe and effective in clinical trials, The Clinical Audit in Pharmaceutical Development · recommends establishing auditing and quality assurance at the beginning of a clinical study · describes Good Clinical Practices (GCPs) and the role of regulatory agencies in the review, validation, and auditing processes · outlines the clinical process, from trial design through report writing · compares and contrasts United States and international regulatory statutes · identifies monitoring as the key to guaranteeing high-quality data · focuses on the role of the clinical audit in achieving unity in a multinational study · discusses the worldwide influence of the US Food and Drug Administration audit · analyzes findings from previous FDA clinical audits to reveal trends and future directions · provides guidelines for fraud detection and considers the ramifications of falsified data · and more! Confirming that all clinical information has been properly collected and reported, The Clinical Audit in Pharmaceutical Development is a crucial reference for clinical and research pharmacists and pharmacologists; biostatisticians; clinical research associates, coordinators, and investigators; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

The Clinical Audit in Pharmaceutical Development

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Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children – 50 to 75 percent – have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence.”Addressing the Barriers to Pediatric Drug Development” is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.

Addressing the Barriers to Pediatric Drug Development: Workshop Summary

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This book focuses on the safety efforts being implemented in paediatric drug development. Although children suffer from many of the same diseases as adults and are often treated with the same drugs, only about one-third of the drugs that are prescribed for children have been studied and labelled for paediatric use. This has placed children taking drugs for which there have not been adequate paediatric drug studies at risk of being exposed to ineffective treatment or receiving incorrect dosing. In order to encourage the study of more drugs for paediatric use, Congress passed the Best Pharmaceuticals for Children Act (BPCA) in 2002 to provide marketing incentives to drug manufacturers for conducting paediatric drug studies. Drug manufacturers may obtain six months of additional market exclusivity for drugs on which they have conducted paediatric studies in accordance with pertinent law and regulations. This book also evaluates the impact of BPCA on labelling drugs for paediatric use and the process by which the labelling was changed, and illustrates the range of diseases treated by the drugs studied under BPCA. Additionally this book provides guidance on the role and timing of animal studies in the non-clinical safety evaluation of therapeutics intended for the treatment of paediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in paediatric patients and makes recommendations on non-clinical testing. This book consists of public documents which have been located, gathered, combined, reformatted, and enhanced with a subject index, selectively edited and bound to provide easy access.

Safety Efforts in Pediatric Drug Development

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A COMPREHENSIVE AND PRACTICAL GUIDE TO STABILITY TESTING IN PHARMACEUTICAL DEVELOPMENT

Stability testing is required to demonstrate that a pharmaceutical product meets its acceptance criteria throughout its shelf life and to gain regulatory approval for commercialization. Assessing drug product stability and safety can be quite complicated, and stability profile can impact many functional areas, including analytical testing, formulation development, toxicology, quality, and regulatory affairs.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices is the first volume to cover all aspects of stability testing in pharmaceutical development. It presents a scientific understanding of regulations and balances methodologies and best practices. Comprising 17 chapters, it provides a wealth of resources for pharmaceutical companies, educational institutions, and manufacturing laboratories to use as either a supplementary text for stability training courses or as a reference book for pharmaceutical practitioners.

Topics covered include:

• Latest regulations for stability testing, including cGMP requirements, ICH guidelines, and global guidances from WHO, ASEAN, EMRO, and other regions.
• Post-approval considerations and regulatory filing strategies to support a global supply chain.
• Methodologies, including development of a stability-indicating method, method validation, and transfer. This book also discusses physical stability, non-chromatographic methodologies, and spectroscopic applications.
• Setting specifications, monitoring impurities, and establishing shelf-life of pharmaceutical products.
• Data management, including stability reports, CMC, and discussion of out-of-specification (OOS) and out-of-trend (OOT).
• USP-NF testing in support of stability.
• Current industry best practices on stability operation, validation, and calibration of stability chambers including considerations for photo-stability testing.
• Discussion of matrixing and bracketing to support reduced stability testing.
• Overview of stability programs for biologics and drug-in-devices pharmaceutical products.

This collective work was written by a group of prominent international experts, who have been directly responsible for instituting industry best practices and establishing the current stability guidelines.

Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices

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Presenting recent applications in clinical development, pharmacokinetic/ pharmacodynamic modeling, and clinical trial simulation, this in-depth reference studies the role of biomarkers in successful drug formulation and development—utilizing the latest discoveries in biomarker science to determine the safety and efficacy of emerging drug compounds.

Biomarkers in Clinical Drug Development

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To help prepare you for the realities of working with clients affected by addictions, this beneficial text provides you with the necessary tools needed to competently translate addictions theory into practice. It offers a thorough examination of a range of models and perspectives for helping, and it encourages critical thinking to best match approaches with clients and situations. Presented in a work-text format, this book is full of cases, exercises, role-plays, and questions to increase your understanding of concepts and application to practice.

Alcohol, Other Drugs and Addictions: A Professional Development Manual for Social Work and the Human Services